(A)
Except as provided in paragraphs (B) and (C) of this
rule, any person is exempt from the requirements for a license set forth in
this chapter and Chapter 3701:1-58 of the Administrative Code, provided that
such person receives, possesses, uses, transfers, owns, or acquires capsules
containing thirty-seven kilobecquerels (one microcurie) carbon-14 urea
(allowing for nominal variation that may occur during the manufacturing
process) each, for "in vivo" diagnostic use for humans.

(B)
Any person who
desires to use the capsules for research involving human subjects shall apply
for and receive a specific license under Chapter 3701:1-58 of the
Administrative Code.

(C)
Any person who desires to manufacture, prepare,
process, produce, package, repackage, or transfer for commercial distribution
such capsules shall apply for and receive a specific license under Chapter
3701:1-46 of the Administrative Code.

(D)
Nothing in this
rule relieves persons from complying with applicable United States food and
drug administration, other federal, and state requirements governing receipt,
administration, and use of drugs.